Clinical trial

Hand-Sewn vs. Stapled Anastomosis in SADI-S: Early Postoperative Complications.

Invitation only · Not applicable · 1 countries · Registry ID NCT07348146

Invitation onlyNot applicableInterventional

What this study is about

This study aims to compare the stapled and handsewn techniques of duodeno-ileal anastomosis in SADI-S regarding short-term outcomes in the form of anastomotic leak rate and anastomotic stricture rate, operative time, post-operative hospital stay, and complication rate (Clavien-Dindo≥ II).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionMetabolic Surgery, Obesity & Overweight

Full registry criteria

Inclusion Criteria: 1. Age between 18-70 2. Patients who will undergo SADI-S surgery Exclusion Criteria: 1. Patients with severe medical conditions such as heart failure and interstitial lung disease. 2. Patients with short bowel 3. Patients with severe GERD 4. Patients with cognitive and intellectual impairment with poor compliance to treatment and dietary supplements 5. Difficulty in intraoperative bowel measurement, i.e., extensive adhesions.

Treatments and study arms

Hand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S)

Procedure

Arm 1 - Hand-sewn Duodeno-Ileal Anastomosis Following sleeve gastrectomy, a hand-sewn duodeno-ileal anastomosis is performed in two layers, with the inner layer constructed using absorbable barbed sutures and the outer reinforcing layer using absorbable monofilament sutures. Approximately 300 cm of the distal ileum from the ileocecal junction is used for the anastomosis. All procedures are performed by the same surgeon following a standardized operative protocol.

Stapled Single Anastomosis Duodena-ileal Sleeve

Procedure

Arm 2 - Stapled Single Anastomosis Duodena-ileal Sleeve Following sleeve gastrectomy, a stapled duodeno-ileal anastomosis is created using endoscopic linear stapling devices, followed by closure of the enterotomy in a single layer using absorbable barbed sutures. Approximately 300 cm of the distal ileum from the ileocecal junction is used for the anastomosis. All procedures are performed by the same surgeon following a standardized operative protocol.

Primary outcomes

Intestinal InjuryOne month after surgery

Anastomotic Leak Rateone month after the surgery

Post operative BleedingOne month after surgery

Anastomotic StirctureSix months after surgery

Operative TimeImmediately after surgery

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Kasr Alainy Medical School, Cairo University🇪🇬 Cairo, Egypt

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